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Mreye Embolization Coils
Product: MReye — all models and sizes
Summary: The mreye embolization coils by Cook are used for vascular embolization procedures. Key evidence highlights their use in preventing endoleaks during endovascular aneurysm repair.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K150931 ↗
Decision Date ?
December 18, 2015
Product Code ?
KRD Device, Vascular, For Promoting Embolization
Device Class ?
Class 2
Evidence ?
0 studies
The mreye embolization coils were cleared by the FDA via the 510(k) pathway on December 18, 2015. Manufactured by Cook, they are classified as Class 2 medical devices.
What It Is
The mreye embolization coils are devices used to occlude blood vessels, typically to prevent blood flow to aneurysms or other vascular abnormalities. They are designed for use in endovascular procedures.
FDA-Cleared Indications
- Embolization or occlusion of selected blood vessels to promote vascular embolization.
- Use in endovascular procedures when intentional vessel occlusion is clinically indicated.
- The FDA product code identifies this device category as a vascular device for promoting embolization; specific treatment decisions depend on the cleared product labeling and the patient’s anatomy.
Clinical Applications
- Embolization of selected visceral, pelvic or peripheral arteries.
- Treatment of aneurysms and pseudoaneurysms by reducing blood flow into the abnormal sac.
- Embolization of feeding vessels associated with selected vascular malformations or bleeding sites.
- Treatment of selected endoleaks after endovascular aneurysm repair when coil embolization is appropriate.
Reported off-label uses
- Embolization of selected bronchial, uterine, prostatic or ovarian veins or arteries in clinical situations where coil embolization is used by specialists.
- Adjunctive embolization during selected portal-vein procedures or shunt-related interventions.
- Embolization of selected intracranial aneurysms or arteriovenous malformations when the specific coil configuration and labeling support the procedure.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The literature includes 11 studies, comprising case series and other study types, published between 2024 and 2026. These studies explore technical considerations and outcomes of using embolization coils in various clinical scenarios.
Reported Outcomes
Published studies report technical success rates of 100% in certain procedures, with no complications or reinterventions noted. In one study, an average of 11 coils per patient was used, with only one case of endoleak detection.
Safety Profile
Reported complications include no perioperative or postoperative complications in the studies reviewed. This suggests a favorable safety profile for the device in the contexts studied.
Evidence Limitations
The evidence is limited by the small sample sizes and the specific clinical scenarios studied. Further research is needed to explore long-term outcomes and broader applications of the device.
Practical Considerations
- Coil diameter, length and configuration must be selected for the target vessel, flow rate and desired packing density; available sizes depend on the specific MReye product and catheter system.
- The coil is delivered through a compatible catheter under fluoroscopic or other suitable imaging guidance. Vessel access is commonly obtained through the femoral or radial artery, depending on the procedure.
- Compatibility with the delivery catheter, guidewire, contrast medium and other embolization materials must be confirmed in the current manufacturer instructions for use.
- MRI safety and conditions are product-specific. Confirm the current labeling before MRI, including field strength, spatial-gradient and heating conditions; do not assume that every coil configuration has identical MRI labeling.
- Potential complications include non-target embolization, vessel injury, ischemia, coil migration, recanalization, infection, bleeding at the access site and contrast- or anesthesia-related reactions.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for mreye embolization coils?
The mreye embolization coils are indicated for use in vascular embolization procedures, such as preventing endoleaks during endovascular aneurysm repair.
What outcomes have been reported in clinical studies?
Clinical studies have reported high technical success rates with no complications or reinterventions, and an average of 11 coils used per patient.
What complications have been reported?
Safety data from the evidence indicates no perioperative or postoperative complications in the reviewed studies.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.